Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis - Full Text View

Sponsored by:	INO Therapeutics
Information provided by:	INO Therapeutics
ClinicalTrials.gov Identifier:	NCT00570349

Purpose

The primary objective of the trial is to assess the safety and tolerability of inhaled NO when administered by nasal cannula over a 44 hour period to clinically stable CF subjects. Toxicity is to be defined as a drop in oxygen saturations, a decline in FEV1, or an increase in methemoglobin.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: Nitric Oxide for Inhalation	Phase I Phase II

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Nitric oxide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis

Further study details as provided by INO Therapeutics:

Primary Outcome Measures:

Safety/tolerability of drug, assessed by physical exams/monitoring vital signs/methemoglobin. Evaluation of safety include: oxygen saturation/methemoglobin levels/FEV1. Tolerability assessed subjectively by evaluating reporting of symptoms. [ Time Frame: 44 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the difference in sputum bacterial density before and after NO inhalation. Assess the difference in lower airway inflammatory measures before and after NO inhalation [ Time Frame: 44 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	18
Study Start Date:	July 2004
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Low Dose Cohort: Experimental Subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug:placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo)	Drug: Nitric Oxide for Inhalation NO or nitrogen will be administered via nasal cannula over a 44 hour period
High-Dose Cohort: Experimental Subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug:placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo)	Drug: Nitric Oxide for Inhalation The NO or nitrogen will be administered via nasal cannula over a 44 hours period.

Detailed Description:

This trial will be a randomized, double-blind, placebo-controlled dose-escalating design. Following enrollment, each of the 18 CF participants will be admitted to the Inpatient Clinical Research Center (CRC) Unit for 48 hours. The subjects will be enrolled sequentially into one of 2 cohorts of 9 patients each in a 2:1 fashion (active drug: placebo): initially a low-dose NO cohort (6 active: 3 placebo) followed by a high-dose NO cohort (6 active: 3 placebo). The NO or placebo (nitrogen) will be administered via nasal cannula over a 44 hour period. The patient, investigator, study coordinators and respiratory therapists will not know which drug (NO or placebo) the patient is receiving. The lead study RT will be unblinded if it is required.

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed diagnosis of CF
12 years of age and older
FEV1 greater than 40% of predicted
Resting awake oxygen saturation of at least 88%
Stable pulmonary disease as defined by both clinical impression and having had no recent hospitalizations or changes in antibiotic regimen within 1 month prior to enrollment
Signed IRB approved informed consent

Exclusion Criteria:

Pulmonary exacerbation resulting in antibiotic treatment (except prophylactic antibiotics) within 1 month of enrollment
Isolation of B. cepacia from a respiratory tract culture within 6 months
Severe nasal obstruction at the time of screening
Receipt of any aerosolized experimental or investigational drugs within 1 month of enrollment
Pregnancy (a negative pregnancy test must be documented prior to enrollment if applicable)
Patients who have received treatment with nitric oxide for inhalation within 24 hours prior to study initiation or other investigational medications within 24 hours.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00570349

Locations

United States, Colorado
The Children's Hospital	Recruiting
Denver, Colorado, United States, 80218
Contact: Churee Pardee, RN 303-861-6162
Principal Investigator: Scott Sagel, MD

Sponsors and Collaborators

INO Therapeutics

Investigators

Principal Investigator:

Scott Sagel, MD

The Children's Hospital

More Information

Responsible Party:	INO Therapeutics ( Rob Small )
Study ID Numbers:	INOT 50
Study First Received:	December 6, 2007
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00570349
Health Authority:	United States: Food and Drug Administration

Keywords provided by INO Therapeutics:

Inhaled Nitric oxide
Cystic Fibrosis

Study placed in the following topic categories:

Nitric Oxide
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis

Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases
Cystic fibrosis

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents

Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 11, 2009